Job Description

As a Clinical Research Assocate you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

What will you be doing?

• Works on multiple oncology trials
• Quality of life focus wtih Regional Travel
• Demonstrated leadership, through involvement in specific initiatives when needed, and/or SME to systems and/or processes • Mentors/coaches junior flex team
• Acts as Lead SM-training other SMs on study
• Develops site start up documents for studies including SIV agenda
• Provides SM “voice” when reviewing study documents (e.g. Monitoring Guidelines)
• Represents LTMs or SMs on SMTs/meetings
• Takes over LTM role reports review (SQV, SMV, SCV) for sites assigned to other SMs from the same trial
• Supports country budget development and/or contract negotiation in liaison with CCS colleagues
• Assists with ASV
• Metrics/KPIs: Metrics/KPIs governing these services are outlined in the Quality Oversight Plan (QOP) document.

Interfaces – Primary/Other:

• Primary interfaces: Provider Functional Manager, Clinical Trial Assistant, Local Trial Manager and Central Study Team for assigned clinical trials.
• Other Interfaces: Study Responsible Physician, Regional Quality and Compliance. Manager/Specialist, Local Drug Safety Officer (where required) and Site Manager team; Investigators and their delegates at site (trial personnel including study coordinators, pharmacists, etc.)

What you need to have:

• Based in the Montreal area, Quebec
• Bilingual – French and English
• Have a minimum of a B.Sc., R.N., or equivalent degree, preferably in Biological Sciences
• Have a minimum of 2 year experience in monitoring pharmaceutical industry clinical trials
• Knowledge of several therapeutic areas is an asset, including oncology – preferably Hematology, Prostate Cancer, Lung Cancer, Early development (Phase 1) etc.
• Analytical/risk-based monitoring experience is an asset
• Ability to actively drive patient recruitment strategies at assigned sites
• Ability to partner closely with investigator and site staff to meet all study timelines
• Ability to operate and use various systems and databases (e.g. CTMS, EDC, TMF, various dashboards/metrics, IWRS, safety reporting).
• Possess strong communication and influencing skills to effectively manage study sites both remotely and face to face. Strong team member and self-starter with the ability to work independently.
• Have an in-depth knowledge of Good Clinical Practice, ICH guidelines and local regulatory requirements.
• Need to travel up to 50%
• To qualify, applicants must be legally authorized to work in Canada, and should not require, now or in the future, sponsorship for employment visa status.

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